To: russet who wrote (12133 ) 2/19/2003 9:47:13 PM From: Mark Bartlett Read Replies (1) | Respond to of 14101 russett, I have a few questions. 1) All medications that are taken for prolonged periods of time have labelling warnings or indicators that suggest when the medication may need to be discontinued. Why would that not suffice with Pennsaid? Surely it can not be that difficult to include some comment for that purpose. It is clear from the trial data that some people had to be removed from using Pennsaid for irritation issues -- not a lot, but some. So it seems apparent to me that these indicators are readily available. If it take 12 weeks or 2 years to develop sensitization, so be it -- if it happens then you stop using it. 2) Is DMX being held to a different standard than other companies to obtain approval? For example, the data for the Cox2s was only for a 12 week period. Apparently that was OK. Even now, when more long-term data is available, they are still touted as superior to the older NSAIDS despite there being numerous types of evidence that suggests they may have other issues. My own brother ended up on the hospital due to Celebrex issues. 3) How does one get any new medication approved for long-term use when trials are not that long? It seems to me that there is no way to really be sure that any med developed for long-term use is safe, until it has been used for whatever period of time you are interested in approving. It seems to be a no-win situation. 4) Use of older NSAIDS has been proven to lead to deaths and hospitalizations of users. Apparently, in the hundreds of people who have used Pennsaid, there have been no such complaints. It seems to me that there are some serious risk -benefit issues here. One being a skin rash/sensitization that resolves after use stops, and potentially dying (where you are stopped for good). 5) I do not have the Pennsaid paper in front of me at the moment, but in terms of how long the potential exists for chemicals to be transported through the skin -- I seem to recall that the pharmakokinetics re "transportation time" is actually only a few minutes. That is not to say that it would not last up to 20 minutes, but rather the majority of anything that is going to be transported will happen quite quickly. Since I do not have the paper readily available, I may be wrong on this point. MB